Procedures and practices for the validation of bioanalytical methods using dried blood spots: A review

Bioanalysis

Volumn 6, Issue 18, 2014, Pages 2481-2514

  Jager, Nynke G L ^a   Rosing, Hilde ^a   Schellens, Jan H M ^a   Beijnen, Jos H ^a  

^a SLOTERVAART HOSPITAL   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD SAMPLING; CALIBRATION; DILUTION; DRIED BLOOD SPOT TESTING; DRUG DETERMINATION; HEMATOCRIT; HUMAN; LIMIT OF QUANTITATION; PRACTICE GUIDELINE; QUALITY CONTROL PROCEDURES; QUANTITATIVE ANALYSIS; REVIEW; STANDARD; STORAGE TEMPERATURE; VALIDATION PROCESS; ANIMAL; INDICATOR DILUTION CURVE; LABORATORY DIAGNOSIS; LIMIT OF DETECTION; PROCEDURES; REPRODUCIBILITY;

ANIMALS; DRIED BLOOD SPOT TESTING; HUMANS; INDICATOR DILUTION TECHNIQUES; LIMIT OF DETECTION; REPRODUCIBILITY OF RESULTS; SPECIMEN HANDLING;

EID: 84922653632     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.185     Document Type: Review

References (94)

1. Guthrie R, Susi A. A simple phenylalanine method for detecting phenylketonuria in large populations of newborn infants. Pediatrics 32, 338-343 (1963).
2. Wickremsinhe E, Abdul B, Huang N et al. Dried blood spot sampling: coupling bioanalytical feasibility, blood-plasma partitioning and transferability to in vivo preclinical studies. Bioanalysis 3(14), 1635-1646 (2011).
3. Blessborn D, Romsing S, Bergqvist Y, Lindegardh N. Assay for screening for six antimalarial drugs and one metabolite using dried blood spot sampling, sequential extraction and ion-trap detection. Bioanalysis 2(11), 1839-1847 (2010).
4. Pham R, Moore E, Wells M et al. Dried blood spot (DBS) evaluation of compounds with differing physiochemical properties and card lots using LC-MS/MS. Am. Pharm. Rev. (2011). www.americanpharmaceuticalreview.com/Featured-Articles/37314-Dried-Blood-Spot-DBS-Evaluation-of-Compounds-with-Differing-Physiochemical-Properties-and-Card-Lots-Using-LC-MS-MS/
5. US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services. 4-10 (2001).
6. European Medicines Agency. Guideline on Bioanalytical Method Validation. Eur. Med. Agency 4-10 (2011).
7. Hoogtanders K, van der Heijden J, Christiaans M, Edelbroek P, van Hooff JP, Stolk LML. Therapeutic drug monitoring of tacrolimus with the dried blood spot method. J. Pharm. Biomed. Anal. 44(3), 658-664 (2007).
8. Spooner N, Lad R, Barfield M. Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal. Chem. 81(4), 1557-1563 (2009).
9. Li W, Tse FLS. Dried blood spot sampling in combination with LC-MS/MS for quantitative analysis of small molecules. Biomed. Chromatogr. 24(1), 49-65 (2010).
10. Timmerman P, White S, Globig S, Lüdtke S. EBF recommendation on the validation of bioanalytical methods for dried blood spots. Bioanalysis 3(14), 1567-1575 (2011).
11. Timmerman P, White S, Cobb Z, de Vries R, Thomas E, van Baar B. Update of the EBF recommendation for the use of DBS in regulated bioanalysis integrating the conclusions from the EBF DBS-microsampling consortium. Bioanalysis 5(17), 2129-2136 (2013).
12. Edelbroek PM, van der Heijden J, Stolk LML. Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther. Drug Monit. 31(3), 327-336 (2009).
13. Meesters R, Hooff G, van Huizen N. Impact of internal standard addition on dried blood spot analysis in bioanalytical method development. Bioanalysis 3(20), 2357-2364 (2011).
14. van Baar B, Verhaeghe T, Heudi O. IS addition in bioanalysis of DBS: results from the EBF DBS-microsampling consortium. Bioanalysis 5(17), 2137-2145 (2013).
15. Vu DH, Koster RA, Alffenaar JWC, Brouwers JRBJ, Uges DRA. Determination of moxifloxacin in dried blood spots using LC-MS/MS and the impact of the hematocrit and blood volume. J. Chromatogr. B 879(15-16), 1063-1070 (2011).
16. De Vries R, Barfield M, van de Merbel N et al. The effect of hematocrit on bioanalysis of DBS: results from the EBF DBS-microsampling consortium. Bioanalysis 5(17), 2147-2160 (2013).
17. Denniff P, Spooner N. The effect of hematocrit on assay bias when using DBS samples for the quantitative bioanalysis of drugs. Bioanalysis 2(8), 1385-1395 (2010).
18. Den Burger JCG, Wilhelm AJ, Chahbouni A, Vos RM, Sinjewel A, Swart EL. Analysis of cyclosporin A, tacrolimus, sirolimus, and everolimus in dried blood spot samples using liquid chromatography tandem mass spectrometry. Anal. Bioanal. Chem. 404(6-7), 1803-1811 (2012).
19. Le T, Bhushan V. First Aid for the USMLE Step 1. 23rd Edition. McGraw-Hill Education, NY, USA (2013).
20. Cobb Z, de Vries R, Spooner N, Williams S. In-depth study of homogeneity in DBS using two different techniques: results from the EBF DBS-microsampling consortium. Bioanalysis 5(17), 2161-2169 (2013).
21. O'Mara M, Hudson-Curtis B, Olson K, Yueh Y. The effect of hematocrit and punch location on assay bias during quantitative bioanalysis of dried blood spot samples. Bioanalysis 3(20), 2335-2347 (2011).
22. Jager NGL, Rosing H, Schellens JHM, Beijnen JH. Determination of tamoxifen and endoxifen in dried blood spots using LC-MS/MS and the effect of coated DBS cards on recovery and matrix effect. Bioanalysis 6, 21 (2014).
23. Koster RA, Alffenaar J-WC, Greijdanus B, Uges DRA. Fast LC-MS/MS analysis of tacrolimus, sirolimus, everolimus and cyclosporin A in dried blood spots and the influence of the hematocrit and immunosuppressant concentration on recovery. Talanta 115, 47-54 (2013).
24. Chen X, Zhao H, Hatsis P, Amin J. Investigation of dried blood spot card-induced interferences in liquid chromatography/mass spectrometry. J. Pharm. Biomed. Anal. 61, 30-37 (2012).
25. Black J, Layloff T. Summer of 1995-Mailbox temperature excursions in St Louis. Pharmacopeial Forum 22, 3305 (1996).
26. Hewson C, Shen CC, Strachan C, Norris P. Personal medicines storage in New Zealand. J. Prim. Health Care 5(2), 146-150 (2013).
27. Liu G, Snapp HM, Ji QC. Internal standard tracked dilution to overcome challenges in dried blood spots and robotic sample preparation for liquid chromatography/tandem mass spectrometry assays. Rapid Commun. Mass Spectrom. 25(9), 1250-1256 (2011).
28. Koal T, Burhenne H, Römling R, Svoboda M, Resch K, Kaever V. Quantification of antiretroviral drugs in dried blood spot samples by means of liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 19(21), 2995-3001 (2005).
29. Aburuz S, Millership J, McElnay J. Dried blood spot liquid chromatography assay for therapeutic drug monitoring of metformin. J. Chromatogr. B. 832(2), 202-207 (2006).
30. Lejeune D, Souletie I, Houzé S et al. Simultaneous determination of monodesethylchloroquine, chloroquine, cycloguanil and proguanil on dried blood spots by reversephase liquid chromatography. J. Pharm. Biomed. Anal. 43(3), 1106-1115 (2007).
31. Ter Heine R, Rosing H, van Gorp ECM et al. Quantification of protease inhibitors and non-nucleoside reverse transcriptase inhibitors in dried blood spots by liquid chromatography-triple quadrupole mass spectrometry. J. Chromatogr. B. 867(2), 205-212 (2008).
32. Garcia Boy R, Henseler J, Mattern R, Skopp G. Determination of morphine and 6-acetylmorphine in blood with use of dried blood spots. Ther. Drug Monit. 30(6), 733-739 (2008).
33. Ter Heine R, Rosing H, van Gorp ECM, Mulder JW, Beijnen JH, Huitema ADR. Quantification of etravirine (TMC125) in plasma, dried blood spots and peripheral blood mononuclear cell lysate by liquid chromatography tandem mass spectrometry. J. Pharm. Biomed. Anal. 49(2), 393-400 (2009).
34. Ter Heine R, Hillebrand MJX, Rosing H et al. Quantification of the HIV-integrase inhibitor raltegravir and detection of its main metabolite in human plasma, dried blood spots and peripheral blood mononuclear cell lysate by means of high-performance liquid chromatography tandem mass spectrometry. J. Pharm. Biomed. Anal. 49(2), 451-458 (2009).
35. Van der Heijden J, de Beer Y, Hoogtanders K et al. Therapeutic drug monitoring of everolimus using the dried blood spot method in combination with liquid chromatography-mass spectrometry. J. Pharm. Biomed. Anal. 50(4), 664-670 (2009).
36. Liang X, Li Y, Barfield M, Ji QC. Study of dried blood spots technique for the determination of dextromethorphan and its metabolite dextrorphan in human whole blood by LC-MS/MS. J. Chromatogr. B. 877(8-9), 799-806 (2009).
37. Wilhelm AJ, den Burger JCG, Vos RM, Chahbouni A, Sinjewel A. Analysis of cyclosporin A in dried blood spots using liquid chromatography tandem mass spectrometry. J. Chromatogr. B. 877(877), 1595-1598 (2009).
38. Damen CWN, Rosing H, Schellens JHM, Beijnen JH. Application of dried blood spots combined with high-performance liquid chromatography coupled with electrospray ionisation tandem mass spectrometry for simultaneous quantification of vincristine and actinomycin-D. Anal. Bioanal. Chem. 394(4), 1171-1182 (2009).
39. Wilhelm AJ, den Burger JCG, Chahbouni A, Vos RM, Sinjewel A. Analysis of mycophenolic acid in dried blood spots using reversed phase high performance liquid chromatography. J. Chromatogr. B. 877, 3916-3919 (2009).
40. Déglon J, Lauer E, Thomas A, Mangin P, Staub C. Use of the dried blood spot sampling process coupled with fast gas chromatography and negative-ion chemical ionization tandem mass spectrometry: application to fluoxetine, norfluoxetine, reboxetine, and paroxetine analysis. Anal. Bioanal. Chem. 396(7), 2523-2532 (2010).
41. Suyagh MF, Kole PL, Millership J, Collier P, Halliday H, McElnay JC. Development and validation of a dried blood spot-LC-APCI-MS assay for estimation of canrenone in paediatric samples. J. Chromatogr. B 878(9-10), 769-776 (2010).
42. Suyagh MF, Iheagwaram G, Kole PL et al. Development and validation of a dried blood spot-HPLC assay for the determination of metronidazole in neonatal whole blood samples. Anal. Bioanal. Chem. 397(2), 687-693 (2010).
43. Meesters RJW, van Kampen JJA, Reedijk ML et al. Ultrafast and high-throughput mass spectrometric assay for therapeutic drug monitoring of antiretroviral drugs in pediatric HIV-1 infection applying dried blood spots. Anal. Bioanal. Chem. 398(1), 319-328 (2010).
44. Ingels A-SME, Lambert WE, Stove CP. Determination of gamma-hydroxybutyric acid in dried blood spots using a simple GC-MS method with direct 'on spot' derivatization. Anal. Bioanal. Chem. 398(5), 2173-2182 (2010).
45. Mercolini L, Mandrioli R, Gerra G, Raggi MA. Analysis of cocaine and two metabolites in dried blood spots by liquid chromatography with fluorescence detection: a novel test for cocaine and alcohol intake. J. Chromatogr. A. 1217(46), 7242-7248 (2010).
46. Patel P, Tanna S, Mulla H, Kairamkonda V, Pandya H, Lawson G. Dexamethasone quantification in dried blood spot samples using LC-MS: the potential for application to neonatal pharmacokinetic studies. J. Chromatogr. B 878(31), 3277-3282 (2010).
47. Lad R. Validation of individual quantitative methods for determination of cytochrome P450 probe substrates in human dried blood spots with HPLC-MS/MS. Bioanalysis 2(11), 1849-1861 (2010).
48. Michi M, Ferrari L. Validation of a high-sensitive assay for zatebradine in dried blood spots of human whole blood at pg/ml concentrations using HILIC-MS/MS. Bioanalysis 2(11), 1863-1871 (2010).
49. La Marca G, Malvagia S, Filippi L et al. Rapid assay of rufinamide in dried blood spots by a new liquid chromatography-tandem mass spectrometric method. J. Pharm. Biomed. Anal. 54(1), 192-197 (2011).
50. Ewles MF, Turpin PE, Goodwin L, Bakes DM. Validation of a bioanalytical method for the quantification of a therapeutic peptide, ramoplanin, in human dried blood spots using LC-MS/MS. Biomed. Chromatogr. 25(9), 995-1002 (2011).
51. Saracino MA, Lazzara G, Prugnoli B, Raggi MA. Rapid assays of clozapine and its metabolites in dried blood spots by liquid chromatography and microextraction by packed sorbent procedure. J. Chromatogr. A 1218(16), 2153-2159 (2011).
52. Clavijo CF, Hoffman KL, Thomas JJ et al. A sensitive assay for the quantification of morphine and its active metabolites in human plasma and dried blood spots using high-performance liquid chromatography-tandem mass spectrometry. Anal. Bioanal. Chem. 400(3), 715-728 (2011).
53. Swales JG, Gallagher RT, Denn M, Peter RM. Simultaneous quantitation of metformin and sitagliptin from mouse and human dried blood spots using laser diode thermal desorption tandem mass spectrometry. J. Pharm. Biomed. Anal. 55(3), 544-551 (2011).
54. Hooff GP, Meesters RJW, van Kampen JJ a et al. Dried blood spot UHPLC-MS/MS analysis of oseltamivir and oseltamivircarboxylate-A validated assay for the clinic. Anal. Bioanal. Chem. 400(10), 3473-3479 (2011).
55. Li W, Williams SM, Smith HT, Tse FLS. Quantitative analysis of NIM811, a cyclophilin inhibitor, in human dried blood spots using liquid chromatography-tandem mass spectrometry. J. Chromatogr. B 879(24), 2376-2382 (2011).
56. Römsing S, Lindegardh N, Bergqvist Y. Determination of tafenoquine in dried blood spots and plasma using LC and fluorescence detection. Bioanalysis 3(16), 1847-1853 (2011).
57. Yakkundi S, Millership J, Collier P, Shields MD, McElnay J. Development and validation of a dried blood spot LC-MS/MS assay to quantify ranitidine in paediatric samples. J. Pharm. Biomed. Anal. 56(5), 1057-1063 (2011).
58. Ingels A, de Paepe P. Dried blood spot punches for confirmation of suspected -hydroxybutyric acid intoxications: validation of an optimized GC-MS procedure. Bioanalysis 3(20), 2271-2281 (2011).
59. Reddy TM, Tama CI, Hayes RN. A dried blood spots technique based LC-MS/MS method for the analysis of posaconazole in human whole blood samples. J. Chromatogr. B 879(30), 3626-3638 (2011).
60. Li Y, Henion J, Abbott R, Wang P. Dried blood spots as a sampling technique for the quantitative determination of guanfacine in clinical studies. Bioanalysis 3(22), 2501-2514 (2011).
61. Hinchliffe E, Adaway JE, Keevil BG. Simultaneous measurement of cyclosporin A and tacrolimus from dried blood spots by ultra high performance liquid chromatography tandem mass spectrometry. J. Chromatogr. B. 883-884, 102-107 (2012).
62. La Marca G, Giocaliere E, Villanelli F et al. Development of an UPLC-MS/MS method for the determination of antibiotic ertapenem on dried blood spots. J. Pharm. Biomed. Anal. 61, 108-113 (2012).
63. Ganz N, Singrasa M, Nicolas L et al. Development and validation of a fully automated online human dried blood spot analysis of bosentan and its metabolites using the Sample Card And Prep DBS System. J. Chromatogr. B. 885-886, 50-60 (2012).
64. Thomas A, Geyer H, Schänzer W et al. Sensitive determination of prohibited drugs in dried blood spots (DBS) for doping controls by means of a benchtop quadrupole/Orbitrap mass spectrometer. Anal. Bioanal. Chem. 403(5), 1279-1289 (2012).
65. Saussereau E, Lacroix C, Gaulier JM, Goulle JP. On-line liquid chromatography/tandem mass spectrometry simultaneous determination of opiates, cocainics and amphetamines in dried blood spots. J. Chromatogr. B 885-886, 1-7 (2012).
66. Lawson G, Cocks E, Tanna S. Quantitative determination of atenolol in dried blood spot samples by LC-HRMS: a potential method for assessing medication adherence. J. Chromatogr. B 897, 72-79 (2012).
67. La Marca G, Villanelli F, Malvagia S et al. Rapid and sensitive LC-MS/MS method for the analysis of antibiotic linezolid on dried blood spot. J. Pharm. Biomed. Anal. 67-68, 86-91 (2012).
68. Ansari M, Uppugunduri CRS, Déglon J et al. A simplified method for busulfan monitoring using dried blood spot in combination with liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 26(12), 1437-1446 (2012).
69. Saracino MA, Marcheselli C, Somaini L et al. A novel test using dried blood spots for the chromatographic assay of methadone. Anal. Bioanal. Chem. 404(2), 503-511 (2012).
70. Déglon J, Versace F, Lauer E, Widmer C. Rapid LC-MS/MS quantification of the major benzodiazepines and their metabolites on dried blood spots using a simple and costeffective sample pretreatment. Bioanalysis 4(11), 1337-1350 (2012).
71. Li W, Doherty J, Kulmatycki K, Smith H, Tse F. Simultaneous LC-MS/MS quantitation of acetaminophen and its glucuronide and sulfate metabolites in human dried blood spot samples collected by subjects in a pilot. Bioanalysis 4(12), 1429-1443 (2012).
72. Kralj E, Trontelj J, Paji T, Kristl A. Simultaneous measurement of imatinib, nilotinib and dasatinib in dried blood spot by ultra high performance liquid chromatography tandem mass spectrometry. J. Chromatogr. B 903, 150-156 (2012).
73. Vu DH, Bolhuis MS, Koster RA et al. Dried blood spot analysis for therapeutic drug monitoring of linezolid in patients with multidrug-resistant tuberculosis. Antimicrob. Agents Chemother. 56(11), 5758-5763 (2012).
74. Xu Y, Fang W, Zeng W, Leijen S, Woolf EJ. Evaluation of dried blood spot (DBS) technology versus plasma analysis for the determination of MK-1775 by HILIC-MS/MS in support of clinical studies. Anal. Bioanal. Chem. 404(10), 3037-3048 (2012).
75. Mercolini L, Mandrioli R, Sorella V et al. Dried blood spots: liquid chromatography-mass spectrometry analysis of 9-tetrahydrocannabinol and its main metabolites. J. Chromatogr. A 1271(1), 33-40 (2013).
76. Della Bona ML, Malvagia S, Villanelli F et al. A rapid liquid chromatography tandem mass spectrometry-based method for measuring propranolol on dried blood spots. J. Pharm. Biomed. Anal. 78-79, 34-38 (2013).
77. Sadilkova K, Busby B, Dickerson JA, Rutledge JC, Jack RM. Clinical validation and implementation of a multiplexed immunosuppressant assay in dried blood spots by LC-MS/MS. Clin. Chim. Acta 421, 152-156 (2013).
78. Shah NM, Hawwa a F, Millership JS, Collier PS, McElnay JC. A simple bioanalytical method for the quantification of antiepileptic drugs in dried blood spots. J. Chromatogr. B 923-924, 65-73 (2013).
79. Hoffman JT, Rossi SS, Espina-Quinto R, Letendre S, Capparelli E V. Determination of efavirenz in human dried blood spots by reversed-phase high-performance liquid chromatography with UV detection. Ther. Drug Monit. 35(2), 203-208 (2013).
80. Vnuec Popov T, Marii LC, Prosen H, Vonina DB. Development and validation of dried blood spots technique for quantitative determination of topiramate using liquid chromatography-tandem mass spectrometry. Biomed. Chromatogr. 27(8), 1054-1061 (2013).
81. Lawson G, Cocks E, Tanna S. Bisoprolol, ramipril and simvastatin determination in dried blood spot samples using LC-HRMS for assessing medication adherence. J. Pharm. Biomed. Anal. 81-82, 99-107 (2013).
82. Taylor RR, Hoffman KL, Schniedewind B, Clavijo C, Galinkin JL, Christians U. Comparison of the quantification of acetaminophen in plasma, cerebrospinal fluid and dried blood spots using high-performance liquid chromatographytandem mass spectrometry. J. Pharm. Biomed. Anal. 83, 1-9 (2013).
83. Van der Elst KCM, Span LFR, van Hateren K et al. Dried blood spot analysis suitable for therapeutic drug monitoring of voriconazole, fluconazole, and posaconazole. Antimicrob. Agents Chemother. 57(10), 4999-5004 (2013).
84. Hatami M, Karimnia E, Farhadi K. Determination of salmeterol in dried blood spot using an ionic liquid based dispersive liquid-liquid microextraction coupled with HPLC. J. Pharm. Biomed. Anal. 85, 283-287 (2013).
85. Antelo-Domínguez A, Cocho JA, Tabernero MJ, Bermejo AM, Bermejo-Barrera P, Moreda-Piñeiro A. Simultaneous determination of cocaine and opiates in dried blood spots by electrospray ionization tandem mass spectrometry. Talanta 117, 235-241 (2013).
86. Zheng J-H, Guida L a, Rower C et al. Quantitation of tenofovir and emtricitabine in dried blood spots (DBS) with LC-MS/MS. J. Pharm. Biomed. Anal. 88, 144-151 (2014).
87. Jimmerson LC, Zheng J-H, Bushman LR, Macbrayne CE, Anderson PL, Kiser JJ. Development and validation of a dried blood spot assay for the quantification of ribavirin using liquid chromatography coupled to mass spectrometry. J. Chromatogr. B. 944, 18-24 (2014).
88. Geditz MCK, Lindner W, Lämmerhofer M et al. Simultaneous quantification of mefloquine (+)-and (-)-enantiomers and the carboxy metabolite in dried blood spots by liquid chromatography/tandem mass spectrometry. J. Chromatogr. B. 968, 32-39 (2013).
89. Berm EJJ, Brummel-Mulder E, Paardekooper J, Hak E, Wilffert B, Maring JG. Determination of venlafaxine and O-desmethylvenlafaxine in dried blood spots for TDM purposes, using LC-MS/MS. Anal. Bioanal. Chem. 406, 2349-2353 (2014).
90. Vu DH, Koster RA, Bolhuis MS et al. Simultaneous determination of rifampicin, clarithromycin and their metabolites in dried blood spots using LC-MS/MS. Talanta 121, 9-17 (2014).
91. Jopling J, Henry E, Wiedmeier SE, Christensen RD. Reference ranges for hematocrit and blood hemoglobin concentration during the neonatal period: data from a multihospital health care system. Pediatrics 123(2), e333-e337 (2009).
92. Capiau S, Stove V V, Lambert WE, Stove CP. Prediction of the hematocrit of dried blood spots via potassium measurement on a routine clinical chemistry analyzer. Anal. Chem. 85(1), 404-410 (2013).
93. Driver GA, Patton JC, Moloi J, Stevens WS, Sherman GG. Low risk of contamination with automated and manual excision of dried blood spots for HIV DNA PCR testing in the routine laboratory. J. Virol. Methods 146(1-2), 397-400 (2007).
94. Meesters R, Hooff G, Gruters R. Incurred sample reanalysis comparison of dried blood spots and plasma samples on the measurement of lopinavir in clinical samples. Bioanalysis 4(3), 237-240 (2012).